Author Topic: Restylane problem  (Read 2517 times)

gail2

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Restylane problem
« on: November 03, 2007, 04:09:00 pm »
This is scary as all heck!!  Going in on Fri. for another injection.  Havent had one for over 7 mos.....had Juvy injected in June. This is my first time reading about any bad results. ---
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gail2

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Restylane problem
« Reply #1 on: November 03, 2007, 05:34:00 pm »
Yeah, i know. I\'ve used it for years without problems. I thought i had suddenly developed some sort of allergy - but when the rest of the vial turned cloudy....  Then, believe it or not, i actually had a very teensy amount from a different lot injected. No problem. Then a little more - still no problem. Finally, the rest of the vial, and all is well.
So, it stands to reason that there was a problem with that particular batch. Whether it was with the manuacturing process or something else (frozen, etc.)i can\'t say. And the Medicis rep I spoke with won\'t say either. Yet, there was a certain hesitation in his voice. asking me lots of questions. wanting the remainder of the vial, etc.  Nothing concrete, really, but i got a very strong feeling they have heard this before.

RAVEN

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« Reply #2 on: November 03, 2007, 06:23:00 pm »
So sorry this has happened to you...please keep us updated on how things turn out for you...this is a real heads up for so many of us - might want to post it over on the lip board.  Thanks for the alert.---
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gail2

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Restylane problem
« Reply #3 on: November 04, 2007, 04:10:00 am »
I am glad i could help a little. Does the doctor think removing the Resylane will solve your problem?  If this reaction is caused by byproduct in the resty, would that make it go away or release it all at once? Have they tried giving you prednisone?

There definitely seems to be a "blame the victim" response - you must have done something wrong, that your body is reacting differently than everyone else, etc. That was one reason i wanted to try it again. I wanted to see if i had developed some strange allergic or immune system reaction, or if it was actually just bad Restylane.
I have also leaned (i think it was an FDA memo) that there is some conterfeit product that is getting into the mainstream supply.
I don\'t know what the answer is here. It is certainly not hard to imagine that one could develop an allergy after reading that there are chemical and bacterial (horse strep!) remnants in the product. Yet those rare allergies are explained as YOUR body gone awry - not that the company GAVE you an allergy because they didn\'t rinse the product well enough.
So, my best guesses so far are:
1) breakdown of BDDE
2) allery to excessive bacterial remnants
3) counterfeit product
4) storage problem - too hot, frozen, etc(could this trigger breakdown?)

Good luck. I hope you find relief. Maybe it will resolve itself in a few months when the restylane is all gone?

hpts

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Restylane problem
« Reply #4 on: November 03, 2007, 12:47:00 pm »
I had Restylane on my cheek bone area six months ago.
Everything was great for almost four months, and then I had a delayed reaction to it.
My cheekbones first turn red, then lumpy, then they swell up so much that it closes my eyes and is swollen all the way down to the jowls. The redness turns to a bruised look.
My face is in this state for 5 days then normal for 5 days then the cycle starts over.
I didn\'t think it was anything to do with Resty so I went to an ear, nose and throat doctor and an allergist and $700 later he said that he thinks its a reaction to the Restylane and wanted the batch number so that he could check with the Restylane company to see if any other patients.
I emailed photos to the Dr who gave me Restalyne and he also said it looks like I\'m having delayed severe hypersensitivity for hyaluronic acid.
Both doctors said it was really weird that this was happening 6 months out.
I am travelling in a few days and I\'ll be looking for a doctor to dissolve the Restylane.
Today I look like a pumpkin.
Has this happened to anyone else?

gail2

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« Reply #5 on: November 03, 2007, 03:33:00 pm »
except mine happened within hours. HIDEOUS swelling that gradually subsided over the next 5 days. So far it hasn\'t returned (injected mid June). The leftover restylane from the syringe i was injected with then turned watery and cloudy. The company seems to know what is going on, but is very tightlipped. On their website, they mention not to use and to contact them if material is cloudy, etc. I called and they won\'t tell me anything specific, and seemed very concerned re. liability.

I found the info below (and more) by googling "restylane hypersensitivity". I don\'t know for sure, but my best guess is that some batches are not washed as well as others, resulting in this bad reaction when it breaks down and releases the BDDE. Maybe your reaction ws delayed because it took that long to break down? I wonder if some kind of anti-inflammatory would help you.




Restylane
Restylane, also known as NASHA (non-animal stabilized hyaluronic acid), is prepared in bacterial cultures of equine streptococci through fermentation in the presence of sugar. The product is then alcohol-precipitated, filtered and dried. It’s crosslinked using a butanediol diglycidyl ether (BDDE) and then heat sterilized.

This highly crosslinked material forms a gel that is stiffer and harder than Hylaform. The stiffness of the product makes it much more difficult to wash out the crosslinking chemicals and residual bacterial proteins. The residual amount of the BDDE crosslinking substance that remains in the product is thought to lead to the inflammatory reactions reported with the use of Restylane and Perlane. The stiff, gel-like substance that results after washing and heating the modified HA is then broken into smaller pieces in a similar fashion as is Hylaform. The smallest pieces become the product Restylane Fine Line, the medium size particles become Restylane and the largest particles are packaged as Perlane.

There are two minor drawbacks to Restylane. The first is the presence of bacterial proteins in the resulting injectable product. Protein present in an injectable product can cause antibody formation to that protein with a subsequent allergic response. In a paper published in 2002 by Friedman, data from 144,000 patients injected with Restylane showed a hypersensitivity reaction in one of 1,400 patients treated in 1999. The same paper showed that one in every 5,000 patients treated in 2000 developed a hypersensitivity reaction. In 1999, a new formulation of Restylane was introduced that had a protein load 6-times lower than that found in the previous product. Since that time, hypersensitivity reactions have been said to decline.

The second issue of concern with Restylane is the remnants of the crosslinking agent that remain in the injectable product. Because the stiff gel is difficult to wash, byproducts of the crosslinking agent can remain in the product. Inflammation and swelling have often been described with the use of Restylane and its family members. A recent study comparing Perlane and Hylaform demonstrated an increased incidence of swelling in the Perlane group as compared to the Hylaform group. However, the bacterial origin of Perlane makes it cheaper and easier to produce than animal-derived products, such as Hylaform.

RAVEN

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« Reply #6 on: November 03, 2007, 06:14:00 pm »
Thanks Gail.  So this syringe of Resty (8823) had NOT been left over from your last visit, right?  I will be sure to have my PS check the # before he comes near me. ;-) I would assume (and you know what they say about that word) that the company would put out an alert of some sort.  My PS will not re-use left over Resty says its too dangerous.  I am so glad I read these posts tonight..thanks ladies.---
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gail2

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« Reply #7 on: November 03, 2007, 07:25:00 pm »
It was a fresh syringe, and looked fine at first. I don\'t want to needlessly worry anyone and this is purely speculation on my part. I am hoping this was an isolated problem, but maybe not. I\'m starting to wonder if the normal redness and swelling after  Resty injection is just a smaller version of this. I\'ve been reading about hyaluronic acid products and found some interesting information about one that is injected into the knee joint. Kind of spooked me and now i\'m wondering if i am causing damaging inflammation in my body with every injection.
 
There is no evidence of inflammatory reaction to DUROLANE, and is likely attributable to the non-animal source of NASHA and the mildness of the stabilisation process. In contrast, the extensive modification of other cross-linked HA products using a toxic chemical (divinyl sulfone) can potentially lead to an inflammatory reaction and, therefore, an increased rate of intra-articular degradation.

hpts

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« Reply #8 on: November 03, 2007, 09:50:00 pm »
My batch number was 8574.

I wish I knew if it went cloudy afterwords.

The ear nose throat doc is going to call the drug company to see if any other patients have had trouble with this batch number. Good luck with that!

The doctor that administered the Restylane said that it has been recorded that some people have a severe reaction, and that it doesn\'t have anything to do with the batch number.

I tend to believe both doctors, but don\'t know which case applies to me specifically.

The original doctor emailed me and said he had seen a case of hypersensitivity 3 years ago, but when it happens it usually happens between a few days to 4 weeks later (my delayed reaction was four months and still going at 6 months).

My face is really distorted. My body is fighting so hard that the glands in my throat and behind my knees swell up. It seems that this is very rare, so I hope I\'m not scaring anyone by writing. Some people are allegic to peanuts, some to hair dye, turns out I may be allergic to Restylane. Maybe. Or had a bad batch. I don\'t know!

I have been searching for a month to find a similar situation and couldn\'t find anything. It was such a relief to post a message and then get Gails response which had so much information.

Searching the internet on this subject was very hard as the words "Restylane allergy" or "Restylane Allergic Reaction" or "Restylane swelling" mostly turned up the stock words from the company saying that allergic reactions to Resylane are rare and therefore an allergy test is not required. Seems that the keyword "hypersensitivity" was what I needed. Searching "Restylane Hypersensitivity" revealed a few more cases like mine. Although still hard to find (hopefully because it hasn’t happened to too many other people). Most of the information is in online medical journals and require a subscription, so I couldn\'t read them all.

I should have a prescription for a "Medrol Pak" on Monday. In the meantime I\'m using Advil and antihistamines to ease some of the discomfort, although it doesn\'t reduce the size of my head! I\'ve got to admit that I have felt guilty that I\'ve bought this upon myself, so it was a great releif to post the message and get the responses from Gail and Raven.

RAVEN

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« Reply #9 on: November 04, 2007, 10:03:00 am »
About a year ago I had Radiesse injected for the n/l folds and my PS did an overlay of Resty - it had been suggested to him that it was a "good idea".  When I later went back he said he was told to no longer do the overlay ???  Did either of you have any other product in your face BEFORE this injection of Resty....maybe two different products just dont mix well.  Just a thought.---
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gail2

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Restylane problem
« Reply #10 on: November 04, 2007, 11:18:00 am »
About a year ago I had Radiesse injected for the n/l folds and my PS did an
 overlay of Resty - it had been suggested to him that it was a "good idea".
 When I later went back he said he was told to no longer do the overlay ???
 Did either of you have any other product in your face BEFORE this injection
 of Resty....maybe two different products just dont mix well.  Just a
 thought.

socalgirl

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Restylane problem
« Reply #11 on: November 08, 2007, 01:02:00 am »
> that the glands in my throat and behind my knees swell up.

socalgirl

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Restylane problem
« Reply #12 on: November 08, 2007, 01:06:00 am »
>the glands in my throat and behind my knees swell up.

This is exactly what happened to me when I tried taking hyaluronic acid as a dietary supplement, after reading on another board that some people found it made their lips fuller. It felt like I had an awful head cold! I\'ve had allergic reactions before and always have benedryl (otc) on hand, that helped but it still took almost a week before my glands went down. This was after taking the pills for a few days -- not as delayed a reaction as you had, but I\'ve also had allergic reactions to things (hair dye) that I used for years before without any problem.

I hope you feel better soon.

sgc